what entity is mandated to provide a report on status of patient safety to congress

by Cleo Stamm 8 min read

Patient Safety and Quality Improvement Act of 2005 Statute & Rule

35 hours ago The Patient Safety and Quality Improvement Act of 2005 (PSQIA) establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides Federal privilege and confidentiality protections for patient safety information, called patient safety work product. >> Go To The Portal


Congress vested the authority for implementing the Patient Safety Act with AHRQ by incorporating its provisions into AHRQ's authorizing statute. As the lead Federal agency for patient safety research, AHRQ is an appropriate partner for PSOs and healthcare providers.

Full Answer

Who is responsible for the patient safety database format?

AHRQ lists patient safety organizations pursuant to section 924 of PSQIA and has responsibility for common formats and network of patient safety databases pursuant to section 923. Learn more about the Patient Safety Rule and read the regulations.

What is the Patient Safety Organizations Act?

The purpose of the Act is to encourage providers to work voluntarily with new organizations, known as Patient Safety Organizations (PSOs), to improve patient safety and to reduce the incidence of events that adversely affect patients.

What is joint patient safety reporting for military hospitals?

Joint Patient Safety Reporting All Military Health System Direct Care Direct care refers to military hospitals and clinics, also known as “military treatment facilities” and “MTFs.” direct care facilities must report qualifying patient safety events to the DoD Patient Safety Program through Joint Patient Safety Reporting

What are the requirements of the patient safety rule?

The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements; and each entity or component organization must comply with several additional regulatory requirements.

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WHO reports patient safety to Congress?

Final Report to Congress To Improve Patient Safety Outlines Strategies To Speed Progress. A final report (PDF, 1.16 MB) on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ.

Who enforces patient safety?

OCR enforces these confidentiality protections. AHRQ lists patient safety organizations pursuant to section 924 of PSQIA and has responsibility for common formats and network of patient safety databases pursuant to section 923. Learn more about the Patient Safety Rule and read the regulations.

Who is responsible for patient safety quizlet?

The nurse has the professional responsibility to be engaged in the activities that support a patient-centered safety culture.

What agencies provide regulatory guidance related to safety and quality for patients and staff?

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for Civil Rights (OCR), Department of Health and Human Services (HHS).

What is a federal patient safety organization?

The Patient Safety Organization (PSO) program established federally recognized PSOs to work with health care providers to improve the safety and quality of patient care. The program also creates the first and only comprehensive, nationwide patient safety reporting and learning system in the United States.

What reports are encouraged as a result of the Patient Safety and Quality Improvement Act?

What reports are encourage as a result of the patient safety and quality improvement act? near misses, unsafe conditions, adverse events, events the threaten patient safety.

Which group has ultimate responsibility for maintaining the quality and safety of patient care provided by its healthcare organization?

The board of directors has ultimate responsibility for maintaining the quality and safety of patient care provided by its healthcare organization.

What are the main areas of organizational performance oversight for the governing body of a healthcare organization?

In general, there are three different levels or types of activity that are required to achieve and sustain excellence in the management of organizational performance: (1) Oversight, (2) Leadership, and (3) Execution.

What two major aspects of healthcare employees are responsible for?

Two major aspects of health care that employees are responsible for are: 1)keeping patients and themselves safe and 2)providing the proper quality of care.

Which organizations deal with safety and health issues related to the healthcare industry?

U.S. Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication Number 2015-115, (October 2021). NIOSH/OSHA/CDC Toolkit.

What organizations are leading the charge for patient safety?

The Agency for Healthcare Research and Quality (AHRQ) is the lead federal agency charged with improving the quality and safety of America's health-care system.

Which U.S. Department oversees the Health Care Quality Improvement Act?

The Agency for Healthcare Research and Quality (AHRQ) is the federal agency charged with implementation of the Act.

Who enforces the Patient Safety Act?

Often referred to as the Patient Safety Act, the provisions of this law dealing with PSOs are administered by the Agency for Healthcare Research and Quality (AHRQ) and the provisions dealing with its confidentiality protections are interpreted and enforced by the Office for Civil Rights (OCR).

What agency is responsible for the Patient Safety Act?

To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) published the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs.

What is PSWP in healthcare?

Any information that is eligible to become PSWP reported to a PSO by a healthcare provider is protected. The definition of PSWP ( Patient Safety Rule Section 3.20) provides important detail on what information is eligible for protection and when those protections apply.

What is a PSO readmission?

The PSO readmissions Web page contains helpful information and tools that can be used by such hospitals, and PSOs that work with those hospitals, to address the causes of unnecessary readmissions. In fact, any hospital can work with a PSO on any patient safety issue of the hospital's choice.

What are uniform federal protections?

The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of healthcare providers in patient safety and quality improvement initiatives , such as fear of legal liability or professional sanctions.

What is the Patient Safety Act?

The Patient Safety Act and Rule provide protections that are designed to allay fears of providers of increased risk of liability if they voluntarily participate in the collection and analysis of patient safety events.

What is the role of OCR?

OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system.

What is patient safety event reporting?

Patient safety event reporting systems are ubiquito us in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information. Initial reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals. Voluntary event reporting is therefore a passive form of surveillance for near misses or unsafe conditions, in contrast to more active methods of surveillance such as direct observation of providers or chart review using trigger tools. The Patient Safety Primer Detection of Safety Hazards provides a detailed discussion of other methods of identifying errors and latent safety problems.

What is the Patient Safety and Quality Improvement Act?

The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care providers may choose to work with a PSO and specify the scope and volume of patient safety information to share with a PSO. Because health care providers can set limits on the ability of PSOs to use and share their information, this system does not follow the pattern of traditional voluntary reporting systems. However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily. AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events—in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

What is AHRQ common format?

AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events— in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

How is event reporting used in health care?

A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can be a marker of a positive safety culture within an organization, organizations should resist the temptation to encourage event reporting without a concrete plan for following up on reported events. A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.

Why are event reports limited?

The spectrum of reported events is limited, in part due to the fact that physicians generally do not utilize voluntary event reporting systems.

What are the most frequently reported events in a hospital?

Studies of electronic hospital event reporting systems generally show that medication errors and patient falls are among the most frequently reported events.

What does an event report do?

While event reports may highlight specific concerns that are worthy of attention, they do not provide insights into the epidemiology of safety problems. In a sense, event reports supply the numerator (the number of events of a particular type–and even here, this number only reflects a fraction of all such events) but do not supply the denominator (the number of patients vulnerable to such an event) or the number of "near misses." Event reports therefore provide a snapshot of safety issues, but on their own, cannot place the reported problems into the appropriate institutional context. One way to appreciate this issue is to observe that some institutions celebrate an increase in event reports as a reflection of a "reporting culture," while others celebrate a reduction in event reports, assuming that such a reduction is due to fewer events.

What is the Patient Safety and Quality Improvement Act?

Patient Safety and Quality Improvement Act of 2005. A bill to amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety. 42 U.S.C. ch. 6A, subch.

What is FDA reporting?

By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or

Why is PSWP disclosed?

PSWP may be disclosed to (and the Secretary may require disclosure of PSWP) to investigate or determine compliance with the Patient Safety Act or with HIPAA.

What does PSO stand for in healthcare?

Patient Safety Organization (PSO) must certify that it supports the requirements in the PSQIA and be listed on the Agency for Healthcare Research and Quality (AHRQ) web site.

What is HIPAA privacy and security?

If protected health information is involved , the HIPAA privacy and security rules also apply. By a provider concerning an FDA-regulated product or activity, By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or.

How many people die from medical errors in the US each year?

The Report cited studies that found that at least 44,000 people and potentially as many as 98,000 people die in U. S. hospitals each year as a result of preventable medical errors. Based on these studies and others, the Report estimated that the total national costs of preventable adverse events, including lost income, lost household productivity, permanent and temporary disability, and health care costs to be between $17 billion and $29 billion, of which health care costs represent one-half. One of the main conclusions was that the majority of medical errors do not result from individual recklessness or the actions of a particular group; rather, most errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent adverse events. Thus, the Report recommended mistakes can best be prevented by designing the health care system at all levels to improve safety—making it harder to do something wrong and easier to do something right. As compared to other high-risk industries, the health care system is behind in its attention to ensuring basic safety. The reasons for this lag are complex and varied. Providers are often reluctant to participate in quality review activities for fear of liability, professional sanctions, or injury to their reputations. Traditional state-based legal protections for such health care quality improvement activities, collectively known as peer review protections, are limited in scope: They do not exist in all States; typically they only apply to peer review in hospitals and do not cover other health care settings, and seldom enable health care systems to pool data or share experience between facilities. If peer review protected information is transmitted outside an individual hospital, the peer review privilege for that information is generally considered to be waived. This limits the potential for aggregation of a sufficient number of patient safety events to permit the identification of patterns that could suggest the underlying causes of risks and hazards that then can be used to improve patient safety.

How many ayes and nayes did the House of Representatives vote on in 2005?

It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005 with 428 Ayes, 3 Nays, and 2 Present/Not Voting.

What is the purpose of reporting patient safety events?

The reporting of all patient safety events, even those that don’t reach the patient, allows the DoD PSP to identify, analyze and learn from the sequence of events that may potentially lead to errors before they affect patients.

What is the DoD PSP?

The DoD PSP's Patient Safety Analysis Center, analyzes the reported data and additional data sources to provide cumulative data reports and feedback to the military treatment facilities through the services. These analyses are then used to design and develop programs and tools to assist the MTFs in reducing preventable harm and improve safety throughout the direct care system.

What is military direct care?

All Military Health System Direct Care Direct care refers to military hospitals and clinics , also known as “military treatment facilities” and “MTFs.” direct care facilities must report qualifying patient safety events to the DoD Patient Safety Program through Joint Patient Safety Reporting#N#Goes to the JPSR#N#. Self-reporting is one of the key components in the MHS’s effort to achieve high reliability, and continuously improve and provide the safest patient care possible. Events that are reported encompass all levels of severity and types of medical and dental care.

How to access PSLC?

To access in the PSLC, log into LaunchPad and search “PSLC” in the upper right corner search bar. Choose “PSLC Home” from the results list. Then click “Patient Safety Resources” from the left menu on the PSLC landing page. From the Resources page, click “Joint Patient Safety Reporting” under the Equip column.

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Background

Characteristics of Incident Reporting Systems

  • An effective event reporting system should have four key attributes: While traditional event reporting systems have been paper based, technological enhancements have allowed the development of Web-based systems and systems that can receive information from electronic medical records. Specialized systems have also been developed for specific settings, such as the Intensive Care Unit Safety Reporting System and systems for reporti…
See more on psnet.ahrq.gov

Limitations of Event Reporting

  • The limitations of voluntary event reporting systems have been well documented. Event reports are subject to selection bias due to their voluntary nature. Compared with medical record review and direct observation, event reports capture only a fraction of events and may not reliably identify serious events. The spectrum of reported events is limited, in part due to the fact that physiciansgenerally do not utilize voluntary event reporting systems…
See more on psnet.ahrq.gov

Using Event Reports to Improve Safety

  • A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can b…
See more on psnet.ahrq.gov

Current Context

  • At the national level, regulations implementing the Patient Safety and Quality Improvement Act became effective on January 19, 2009. The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care prov...
See more on psnet.ahrq.gov